1. Field of the Invention
The application relates to a single-use container comprising an over-pressurization relief device, as well as a system provided therewith and a method to prevent over-pressurization.
2. Description of the Related Art
A single-use container is a disposable container, i.e. a container that is discarded after being used. A single-use container may be made of plastic, a synthetic material that can be molded into shape while soft and then set into a rigid or deformable form. Single-use containers are widely used in e.g. the field of bioprocessing, because they are advantageous in terms of cost and flexibility with respect to conventional stainless steel containers. Furthermore, a single-use system is easily sterilizable and helps reduce the risk of contaminations because of its disposability.
However, another decisive factor in the choice of the technology to be employed (i.e. single-use container or steel container) is the safety of the operations. In case of an event of over-pressurization, a breach in the container may ensue, leading to container leakage and loss of sterility. In particular, if biohazardous materials are used, operators may be exposed to dangerous substances.
There are multiple situations where fluid is entering into a container as an input and, if the introduction of the fluid is not properly regulated and/or vented, the pressure of the fluid can lead to the container exceeding the burst pressure. These situations of over-pressurization can include malfunctioning of a primary vent filter due to the presence of condensate, clamping the primary vent filter prior to a fluid addition to the container, over-pressurization due to an incorrect value and/or a faulty regulator of the fluid, pump speed input too high, incorrect integrity testing parameters for the container, and/or some other input without proper regulation, monitoring, and/or venting in place.
In order to protect a stainless steel container from an over-pressurization event, a rupture disc is commonly used. A rupture disc comprises a membrane that fails at a predetermined pressure and is usually made of metal.
US 2011/0005984 discloses a presterilizable filtration system to be disposed of after a single use. The recirculation tank in the system is provided with a safety valve to protect the tank from mechanical destruction by inadmissible excess pressure.
A safety valve may fail to operate and/or not be able to relieve pressure quickly enough. There is therefore a need for a single-use container in which contents can be efficiently relieved in a controlled manner prior to reaching a condition of over-pressurization in the single-use container.